Recall Z-1925-2024 ยท HNN Knife, Ophthalmic
Alcon Research LLC
ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
| Date | May 30, 2024 (initiated Apr 22, 2024) |
| Status | Open, Classified |
| Reason | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance Ophthalmic knives. |
| Root cause | Process control |
| Action | On April 22, 2024 VOLUNTARY MEDICAL DEVICE FIELD CORRECTION letters to customers. Actions to be taken by the Customer / User: If a knife does not perform as expected, or if you feel it does not meet your expectation for sharpness, discontinue use of that specific knife and replace the knife with a new one to avoid potential complications. To acknowledge your receipt of this Voluntary Medical Device Correction notification, please take the following steps: 1. Forward this notification to all departments or organizations using Alcon Ophthalmic Knives. 2. Follow the risk mitigation precautions pr |
| Quantity | 4,930 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Columbia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Ireland, Italy, Japan, Korea, Kuwait, Luxembourg, Mexico, Netherlands, New Zealand, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110166 | CLEARCUT S SAFETY KNIFE Alcon Research, Ltd., May 20, 2011 |